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ISO 8536-6:2025

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Mar 27, 2025

General information

60.60     Mar 27, 2025

ISO

ISO/TC 76

International Standard

11.040.20  

English  

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Scope

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE         The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 8536-6:2016

NOW

PUBLISHED
ISO 8536-6:2025
60.60 Standard published
Mar 27, 2025